Document Control Administrator II

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

• This position is based out of our Grand Island, NY site within BioProduction Group.

Discover Impactful Work:

Meticulous attention to detail is required for the timely release of final product to ensure that customer needs are met while adhering to cGMP quality and compliance standards.

A day in the Life:

• The responsibilities of this role include the review of manufacturing records with strong emphasis on Good Documentation Practices (GDP), the preparation of customer facing documentation, the implementation of change control, the coordination of incoming documentation, support for customer audits, support for site quality training and the archival of controlled documentation applying LIMs, AGILE, Trackwise, Excel, Power Point and MS Outlook.
• The successful candidate will be a highly motivated and team-orientated individual to ensure team goals are achieved in a timely and effective manner. Additionally, the individual should be self-motivated to meet personal developmental goals in an intensely focused, fast-paced environment.
• Daily interaction and collaboration are required between production and quality team members to assist with the timely resolution of quality issues and to improve current documentation practices.

Keys to Success:

Education:

• High School diploma or GED required
• Minimum of 2-year degree in business or technical field or a minimum of 1 year experience in a role which demonstrates attention to detail with high standards to accurate work, preferred

Experience:

• Minimum 1 year working in a GMP environment, preferred
• Batch records knowledge & experience
• Ability to communicate with cross-functional teams
• Ability to handle repetitive work.
• Pharma experience a plus

Knowledge, Skills, Abilities:

• Strong quality-minded individual with prior experience working within a fast-paced cGMP manufacturing environment
• Experience in an administrative setting with strong organizational skills and high attention to detail
• Must exhibit strong problem-solving abilities with emphasis on making sound and ethical decisions
• Possess a positive and professional demeanor
• Places a strong importance on teamwork and peer collaboration
• Possess strong communication abilities, verbally and written
• Experience with Practical Process Improvement (PPI) and/or project management
• Effective presentation abilities required to participate in PPI and site training activities
• Must express excellent interpersonal skills to effectively collaborate with various levels of the customers' organization and Thermo Fisher
• Experience in LIMs, AGILE, Trackwise, Excel, Power Point and MS Outlook

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Compensation and Benefits

The hourly pay range estimated for this position based in New York is $20.00–$25.42.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards